Unicenter, open-label, randomized, noninferiority trial included men with HIV-1 RNA levels \<50 copies/ml for at least 6 months on antiretroviral therapy with DRV/c + TFV/FTC (standar therapy), aged over 18 years. Participants were randomized to either continue standard therapy or switch to DRV/c+3TC. The primary end point was the proportion of subjects with HIV-1 RNA levels \>50 copies/ml after 48 weeks of follow-up according to the snapshot algorithm, with a non-inferiority margin of up to 10%. For statistical analysis, data distribution will be identified using the Kolmogorov-Smirnov test; categorical data will be analyzed using the X2 or Fisher test, as appropriate, and will be expressed as numbers and percentages. Quantitative data will be expressed as medians and interquartile ranges or means with standard deviations. A first analysis will be performed at 24 weeks, with follow-up at 48 weeks. The Student's t-test or the Mann-Whitney U-test will be used for data from independent groups according to their distribution.
Men with HIV infection who are virologically suppressed with DRV/c (800 mg/150 mg) + TFV/FTC (300 mg/200 mg) for at least 6 months
Age ≥18 years-70 years
eGFR ≥30 mL/min
Written informed consent
Withdrawal of informed consent
Loss of medical insurance
Presence of tuberculosis or other opportunistic infection requiring adjustment of the ARV regimen
Incomplete data collected during visits Uncontrolled chronic gastrointestinal conditions Desire to be on a single-dose regimen Coinfection with hepatitis B virus during follow-up if in the DRV/3TC arm Coinfection with hepatitis C virus during follow-up
Parallel
dual therapy
DrugIntervention arm will be dual therapy oh DRV/C 800/150 mg + 3TC 300 mg, this will be compared to standar therapy of 3 drugs with: DRV/c 800/150 mg + TDF/FTC 300/200 mg
Standard Medical Therapy
DrugDRV/c+TDF/FTC
Effectiveness
Individuals with \>50 copies/ml
Non-inferiority
Delta between standard and experimental therapy \<10%
Safety
Adverse events by group and drug tolerability will be reported by device and system, and their severity will be based on the Division of AIDS (DAIDS) Antiretroviral Drug-Associated Adverse Event Severity Scale, which categorizes them in severity from 1 to 4. Grade 1: Mild or no harm; Grade 2: Moderate adverse events or minimal interference with social and functional activities; Grade 3: Severe symptoms causing inability to perform social/functional activities or requiring hospitalization. Grade IV: Those that are life-threatening with symptoms causing inability to perform basic self-care and where intervention is required to prevent permanent deterioration or death.
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José Antonio Mata Marín
Lead sponsor
Instituto Mexicano del Seguro Social
Sponsor institution
